GlaucomaPhase 4NCT01592955
Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU)
A Phase 4 study testing EYEOP1 in people with Glaucoma, run by EyeTechCare at 7 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- EYEOP1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 7 sitesin 4 countries
- Study dates
- May 2012to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory Glaucoma
- IOP > 21 mm Hg
- No previous intraocular surgery or laser treatment during the 90 days before HIFU day
- Age > 18 years
- Informed consent sgned by the subject
Who cannot join
- Normal Tension Glaucoma
- Glaucoma drainage device implanted and still present in the eye to be treated
- History of ocular or retrobulbar tumor
- Ocular infection within 14 days prior to the HIFU procedure
- Aphakic patient
- Ocular disease other than glaucoma that may affect assessment of visual and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinical significant macular edema)
- Pregnant or breast-feeding women, or lack of contraception use among women likely to have a child
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy3 sites
Ospedale San Paolo
Milan, 20142
Institute Ophthalmology - Universita di Parma
Parma, 43121
Clinica Oculistica Universitaria - P-O Oftalmico
Torino, 10149
Switzerland2 sites
Hôpitaux Universitaires de Genève
Geneva, CH-1211
Clinique de Montchoisi - Glaucoma center
Lausanne, CH-1006
Israel1 site
The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.
The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients
- Conditions
- Glaucoma
- Being tested
- EYEOP1
- Keywords
- Glaucoma, Cyclocoagulation, HIFU High Intensity Focused Ultrasound
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYEOP1Device
Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
| Study group | Role | What they receive |
|---|---|---|
| EYEOP1 device | Experimental | cyclocoagulation HIFU Receives: Device: EYEOP1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint : Success / failure rate at 1 year
IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction > 20% compared to the baseline IOP or IOP < 21 mmHg)
Measured: 12 months
Secondary outcomes (1)
Safety measures
Number of device and procedure-related and others complications during follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeTechCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent FARCY, Study director, EyeTechCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592955
- Sponsor's protocol ID
- EYEMUST-2
- Status last verified
- Mar 2013
- First submitted
- 4 May 2012
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13.
PubMed 25982212
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Treatment by Cyclo-coagulation Using High Intensity Focused Ultrasound With the EyeOP1 Medical Device.
- ClinicalTrials.gov ID
- NCT01592955
- Acronym / sponsor ID
- EYEMUST-2
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Cyclocoagulation, HIFU High Intensity Focused Ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- EyeTechCareIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EYEOP1 device | Experimental | Device: EYEOP1cyclocoagulation HIFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Refractory Glaucoma
- IOP > 21 mm Hg
- No previous intraocular surgery or laser treatment during the 90 days before HIFU day
- Age > 18 years
- Informed consent sgned by the subject
Key exclusion criteria (7 listed)
- Normal Tension Glaucoma
- Glaucoma drainage device implanted and still present in the eye to be treated
- History of ocular or retrobulbar tumor
- Ocular infection within 14 days prior to the HIFU procedure
- Aphakic patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYEOP1Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device | Device | EYEOP1 device |
Primary outcome
Efficacy endpoint : Success / failure rate at 1 year
Time frame: 12 months
IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction > 20% compared to the baseline IOP or IOP < 21 mmHg)
1 secondary outcome
Safety measures
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Results publication: PubMed 25982212Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent FARCY study director
EyeTechCare
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EYEOP1 in people with Glaucoma, run by EyeTechCare at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Switzerland, Israel, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint : Success / failure rate at 1 year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01592955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.